BMS Caffeine Adjuvancy Study Acetaminophen-Only Arm Unnecessary – FDA
This article was originally published in The Tan Sheet
An acetaminophen-only treatment arm in Bristol-Myers Squibb's planned clinical study on the efficacy of different caffeine doses in analgesic adjuvancy is unnecessary, FDA says in a recent letter
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Studying the efficacy of 500 mg aspirin/500 mg acetaminophen/130 mg caffeine in a tension headache pain model is sufficient to demonstrate the combination merits Category I status in the internal analgesic drug products tentative final monograph, according to Bristol-Myers Squibb
Bristol Myers-Squibb requests teleconference with FDA in "near future" to discuss several questions generated by agency comments on firm's clinical study proposal for trial comparing effects of aspirin/acetaminophen/ caffeine in varying doses with acetaminophen 1,000 mg alone. Excedrin marketer submitted study protocol in July 2001; FDA responded in February that acetaminophen-only arm is unnecessary, trial should include second pain model other than headache (1"The Tan Sheet" Feb. 25, 2002, p. 9). In May 31 submission, BMS maintains "we believe that many of the issues raised [by FDA] will be answered by providing the agency with a full protocol, rather than the protocol outline we submitted" in July. Complete protocol will be submitted after the teleconference, firm says...
A placebo-controlled, dose-response trial comparing acetaminophen to combinations of caffeine with aspirin and acetaminophen has been proposed by Bristol-Myers Squibb.